NeuralCipher Research overview
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Background: /Objectives: Minzasolmin is a weakly basic drug developed as a potential therapy in Parkinson’s. Amongst the strategies that have been developed to enhance API solubility, pH modification is an effective and patient-centric one that improves solubility by creating a microenvironmental pH around the drug. The objective of this study was to evaluate different formulation approaches to develop an immediate-release tablet or capsule containing fumaric acid as pH-modifier. Methods: Ten formulations were developed varying the degree of contact between the API and pH-modifier. These formulations were then tested in three Biorelevant dissolution conditions to estimate their robustness towards variations in gastric pH. Results: In vitro data showed the best dissolution rate with the over-encapsulated tablet prototype, even in highly buffered achlorhydric conditions and was therefore the most robust formulation toward elevated gastric pH. However, in low buffered achlorhydric conditions the monolayer tablet with acid exhibited similar dissolution rate and prototypes with less close contact between the API and the organic acid also demonstrated improved dissolution rates. Conclusions: These results suggested that the acidic microenvironment may not require such a high degree of contact between the API and the pH-modifier. Selected prototypes will be evaluated in vivo in a future study to evaluate the bio-relevance of the approach.
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